FDA rejects Gilead’s blockbuster-in-waiting
Back before remdesivir became a household name, Gilead Sciences’ most-discussed drug was filgotinib, a treatment for inflammatory disease expected to bring in more than $1 billion a year by 2025. Last night, that all got put in jeopardy.
The FDA rejected Gilead’s application to sell filgotinib as a treatment for rheumatoid arthritis and said it wouldn’t reconsider until the company can provide more data on the drug’s effect on patients’ sperm counts. Gilead is running two studies to determine exactly that, but it won’t have results until some time next year.
The surprise rejection imperils Gilead’s long-term goal of building filgotinib into a major medicine. The plan was to start with rheumatoid arthritis and follow it with approvals in inflammatory bowel disease, psoriatic arthritis, ankylosing spondylitis, and eye inflammation. Until the FDA signs off on the drug’s safety, all of that is up in the air.
The FDA rejected Gilead’s application to sell filgotinib as a treatment for rheumatoid arthritis and said it wouldn’t reconsider until the company can provide more data on the drug’s effect on patients’ sperm counts. Gilead is running two studies to determine exactly that, but it won’t have results until some time next year.
The surprise rejection imperils Gilead’s long-term goal of building filgotinib into a major medicine. The plan was to start with rheumatoid arthritis and follow it with approvals in inflammatory bowel disease, psoriatic arthritis, ankylosing spondylitis, and eye inflammation. Until the FDA signs off on the drug’s safety, all of that is up in the air.
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